EXPANSION MQA Specialist

Piramal Pharma•Lexington, KY

10d

About The Position

The EXPANSION MQA Specialist works in Quality Assurance at the Lexington location and reports to the Quality Supervisor. The role performs in-process process quality assurance activities, environmental monitoring of facilities and utility systems, audits, and Quality Management System support in accordance with Good Manufacturing Practices (GMP) and site-specific Standard Operating Procedures (SOPs). The position is on the night shift.

Requirements

At least 1 year of Quality Assurance or environmental monitoring experience performing quality-related activities in a pharmaceutical manufacturing environment.
Previous experience in QA plant support (IPQA/EM), under strict regulatory guidelines, cGMP, or FDA requirements.
Knowledge of, or ability to understand and follow, job-related regulatory requirements, including cGMP, OSHA, and FDA.
Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and Access.
Ability to communicate effectively both verbally and in writing.
Ability to read and follow written instructions.
Attention to detail.

Nice To Haves

Bachelor's degree in physical or biological sciences or a related scientific field.
Understanding of sterile manufacturing.
Technical writing skills.

Responsibilities

Understand and apply aseptic technique, maintain proper cleanroom behavior, and adhere to cGMP requirements.
Perform in-process QA activities, inspections, labeling, and packaging line clearances according to company SOPs.
Review executed batch records and protocols and meet batch disposition timelines.
Perform environmental monitoring in classified cleanroom areas, including viable surface and air monitoring and non-viable air monitoring.
Sample and test utilities, including water, steam, and compressed gases.
Perform plate enumeration and document results.
Assist with the performance and documentation of cleaning verification sample collection and analysis.
Participate in audits and onsite client interactions as requested by management.
Maintain laboratory instrumentation required for testing, including calibrations.
Help maintain environmental monitoring trend data to support continuous improvement and identify trends.
Participate in microbiology material inventory control for environmental monitoring media plates.
Prepare and summarize site metrics data, and write, read, and revise QA and environmental monitoring SOPs and technical reports.
Conduct GMP investigations, including root cause analyses, risk assessments, and impact evaluations under PPS QMS systems.
Follow applicable health, safety, and environmental compliance regulations, policies, and procedures, and support Quality management as needed.